MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	DYNDTN1529
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch # 24026047, 24075145.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd gravity set was kinked.The following information was received by the initial reporter with the following verbatim it was reported by customer that kink in tube, causing low flow.
Event or Problem Description
Codes update.
Additional Manufacturer Narrative
Investigation summary: (b)(6): it was reported by customer that kink in tube, causing low flow.Samples for the reported failure mode were requested in order to identify any kink and determine a root cause; however, no samples were received for evaluation.Root cause definition: no root cause definition was determinate due to the customer did not provide a sample for evaluation.Corrective and preventive actions: no preventive and corrective actions required since the failure mode could not be confirmed.We regret any inconveniences caused with our product.We will continue to monitor our customer feedback processes for any similar incidences, implement any corrective actions as appropriate.A device history record review for model dyndtn1529 lot number 24026047 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD GRAVITY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21621225
• Report Number: 9616066-2025-00554
• Device Sequence Number: 18249198
• Product Code: FPA
• UDI-Device Identifier: 20080196760173
• UDI-Public: (01)20080196760173(11)240726(17)270726(10)24075145
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: DYNDTN1529
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown